MedTrace Logo

CERAB Technique for Aortoiliac Occlusive Disease

NCT04148456 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2020-07-13

No results posted yet for this study

Summary

To evaluate the safety and efficacy of the CERAB technique as an alternative to surgical reconstruction for treatment of aorto-iliac occlusive disease.

Conditions

  • Aortoiliac Occlusive Disease

Interventions

PROCEDURE

Covered Endovacular Reconstruction of Aortic Bifurcation

* The occlusive lesion is then passed, either subintimal or endoluminal, using crossing wires and catheters. * After gaining re-entry into the lumen of the aorta, angiography will be confirmed proper positioning for those with a subintimal passage. * A 10-12 mm V12 LD balloon expandable ePTFE covered stent (Atrium Medical, Maquet Getinge Group, Hudson, NH) will be expanded in the distal aorta approximately 20 mm above the bifurcation through the 9 Fr sheath. * The proximal 2/3 part of the aortic stent will be flared with a larger balloon, usually 16 mm, thereby creating a funnel shaped covered stent. Subsequently, two 8 mm V12 balloon expandable ePTFE covered stents (Atrium Medical, Maquet Getinge Group, Hudson, NH) will be placed proximally in the distal 1/3 of the aortic stent, and then simultaneously deployed distally into the common iliac arteries creating a tight connection with the first aortic stent, thereby creating the new aortic bifurcation.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • omar M Abd Elhakam, Doctor · Assiut University

  • Ayman E Hassaballah, Professor · Assiut University

  • Haitham A Hassan, Doctor · Assiut University

  • Ahmed K Sayed, Doctor · Assiut University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2023-12-01
Completion
2024-01-01

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04148456 on ClinicalTrials.gov